MPBetreibV

The Medizinprodukte-Betreiberverordnung, usually shortened to MPBetreibV, is the German ordinance that governs the operation of medical devices. It does not regulate who may sell a device or how that device was approved. It regulates what happens once the device is switched on in a real setting, and that is the part a pharmacy tends not to expect. Buying an analyser is a purchase. Operating one is a role with duties attached.

The role has a name. The Betreiber is the natural or legal person who runs the device in their own organisation, which in a pharmacy means the pharmacy itself, represented by the owner. The obligation cannot be passed to the supplier who delivered the device or to the manufacturer who built it. If a Point-of-Care-Test device stands in the consultation room, the pharmacy is its Betreiber and answers for how it is run.

Three duties shape daily practice. The first is instruction. Anyone who uses the device has to be instructed on that specific device by a person competent to give the instruction, before working with it unsupervised, and the instruction is documented with the name of the person and the date. The second is the written record. The ordinance expects a Bestandsverzeichnis of the devices the pharmacy operates and, for the devices it names, a Medizinproduktebuch, so that a device can be traced from delivery through instruction, maintenance and any incident. The third is the recurring check. Measuring devices are subject to the messtechnische Kontrolle, and alongside it run the manufacturer maintenance intervals and the functional checks the Gebrauchsanweisung sets out.

These duties sit beside, not instead of, the checks a pharmacy runs on the measured values themselves. The interne Qualitätskontrolle tells the pharmacy whether the device is measuring correctly today. MPBetreibV tells the pharmacy whether the device may lawfully be operated at all, and by whom. Both belong in the written Qualitätssicherung rather than in one person's memory.

The ordinance also assumes the device is being used inside the intended purpose set out under the IVDR und CE-Kennzeichnung. A device operated outside that purpose is a problem no device log repairs. The workable order is therefore to confirm first what the device is approved for, then to accept the Betreiber duties that come with running it, and only then to put it into service.